Table 2.
Adverse Event | [69] | [70] | [71] | [72] | [73] | [74] | [75] | [76] | Total |
---|---|---|---|---|---|---|---|---|---|
Dizziness | 5 | 7 | 13 | 35 | 4 | 34 | 50 | 4 | 152 |
Headache | 0 | 0 | 9 | 0 | 0 | 7 | 9 | 3 | 208 |
Somnolence | 0 | 0 | 9 | 11 | 0 | 16 | 0 | 0 | 36 |
Muscle Weakness | 3 | 2 | 5 | 0 | 0 | 1 | 0 | 3 | 14 |
Spasticity | 0 | 0 | 3 | 4 | 0 | 0 | 0 | 0 | 7 |
Paraesthesia | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 |
Tremor | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 1 | 4 |
Vertigo | 2 | 1 | 0 | 0 | 0 | 16 | 34 | 4 | 57 |
Tinnitus | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 |
Mood Disruption | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 3 |
Euphoria | 0 | 0 | 9 | 0 | 0 | 0 | 0 | 1 | 10 |
Attention | 0 | 0 | 1 | 0 | 2 | 6 | 0 | 11 | 20 |
Insomnia | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 3 |
Fatigue | 5 | 0 | 5 | 29 | 2 | 16 | 25 | 6 | 88 |
Feeling abnormal | 0 | 0 | 5 | 50 | 0 | 5 | 0 | 0 | 60 |
Feeling hot | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 3 |
Oral Discomfort | 4 | 0 | 3 | 0 | 0 | 19 | 13 | 5 | 44 |
Nausea | 2 | 0 | 1 | 0 | 0 | 12 | 17 | 2 | 34 |
Appetite | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 0 | 5 |
Stomatitis | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Incontinence | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Hypertension | 0 | 1 | 0 | 0 | 0 | 8 | 0 | 0 | 9 |
Pharyngodynia | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 3 |
Vision Blurred | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 4 |
Diarrhoea | 0 | 0 | 0 | 0 | 0 | 7 | 13 | 0 | 20 |
Vomiting | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 5 |
Memory Impairment | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 6 |
Psychomotor Impairment | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 5 |
Total Adverse Events | 806 | ||||||||
Total Participants | 166 | 22 | 24 | 144 | 28 | 312 | 333 | 17 |